Brazil’s health regulator cancels Indian Covaxin vaccine clinical trial

RIO DE JANEIRO, BRAZIL – The Brazilian health regulatory agency (ANVISA) on Monday (26) permanently cancelled clinical trials in the country of Indian Covid-19 Covaxin vaccine, after the laboratory responsible for the immunizer, Bharat Biotech, broke ties with its representative in Brazil.

“The decision was made after a technical assessment that the end of Precisa’s authorization to represent the vaccine in Brazil invalidates compliance with the regulations that govern the conduction of clinical trials of vaccines in the country,” said ANVISA in a statement.

The agency suspended Covaxin clinical studies on Friday after being informed by Bharat of the rupture of the relationship with Brazilian partner Precisa Medicamentos. In addition, ANVISA rejected an application for emergency use of the Covaxin in Brazil submitted by Precisa.

In announcing the end of the agreement with Precisa, Bharat said it would continue to work with ANVISA to complete the process to secure regulatory approval for the vaccine in Brazil.

The negotiations for the purchase of the Covaxin by the Ministry of Health became the target of the Senate Covid CPI (investigative committee) for suspected irregularities, which led the Ministry to suspend the contract to purchase the immunizer, after a R$1.6 billion (US$309 million) budget commitment to pay for the supply of the vaccine doses.

Bharat Biotech claims to have offered the Covaxin vaccine directly to the Brazilian government at US$15 per dose, which would be the lowest international sales price practiced by the laboratory, and said it had no involvement with Precisa’s issues in Brazil.

Source: Exame

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